MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE BLOOD COLLECTION TUBES EDTA; EVACUATED BLOOD COLLECTION TUBES

Model Number 454246, 454209

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint statement (b)(4) : no date of the event could be obtained from the customers.No samples were received for evaluation.No customer pictures were received.No batch numbers were provided by the customer.No further information or clarification was received from the customer.Unfortunately, without basic information, a thorough investigation is not possible.The cause of the event cannot be determined.

Event Description

Customer states: lavender tubes-bubbles causing aspiration errors on dxh 600s.The ref # (b)(4) were mentioned for the lavender tubes.

• Brand Name: VACUETTE BLOOD COLLECTION TUBES EDTA
• Type of Device: EVACUATED BLOOD COLLECTION TUBES
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• Manufacturer (Section G): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• Manufacturer Contact: manfred abel ; 4238 capital drive; monroe, NC 28110 ; 7042617823
• MDR Report Key: 12863584
• MDR Text Key: 282334678
• Report Number: 1125230-2021-00086
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 454246, 454209
• Device Catalogue Number: 454246, 454209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1